P
US10583308B2ActiveUtilityPatentIndex 72

Method and system for directing a localized biological response to an implant

Assignee: PROFUSA INCPriority: Jun 1, 2009Filed: Dec 12, 2016Granted: Mar 10, 2020
Est. expiryJun 1, 2029(~2.9 yrs left)· nominal 20-yr term from priority
Inventors:MCMILLAN WILLIAM AWISNIEWSKI NATALIE
A61M 2230/201A61M 35/00A61M 37/0015A61N 2005/0626A61B 5/14532A61M 2230/005A61N 2005/0645A61B 5/1459A61K 9/0024A61M 5/14276A61K 9/7038A61B 5/14503A61N 5/062A61N 2005/0652A61N 2005/0661A61M 11/00A61M 2205/52A61M 2037/0061A61M 2037/0023A61M 2205/587A61N 2005/067A61N 5/067
72
PatentIndex Score
2
Cited by
277
References
22
Claims

Abstract

The invention provides methods for directing a localized biological response of a mammalian body to an implant disposed within the body. In one embodiment, a delivery system is positioned outside the body and adjacent to the implant within the body. The delivery system comprises a first tissue response modifier effective for directing a localized biological response of the body to the implant. The tissue response modifier is nonsurgically delivered from the delivery system into the body in a quantity effective to direct the localized biological response of the body to the implant. The invention also provides an implant system for long-term use comprising an implant and nonsurgical means for delivering a tissue response modifier through the epidermis of the body, the tissue response modifier effective for directing a localized biological response of the body to the implant.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
       1. A method, comprising:
 delivering a first tissue response modifier from a first patch placed on a surface of a mammalian body, the first tissue response modifier delivered such that the first tissue response modifier does not reach systemic levels in the mammalian body, the first tissue response modifier configured to, at least one of, (1) minimize a first response of the mammalian body to an implantation of an implant or (2) enhance a second response of the mammalian body to the implantation of the implant; 
 placing a second patch on the surface of the mammalian body over the implant after the first patch is placed on the surface of the mammalian body; 
 receiving, from the implant and at the second patch, a signal associated with an analyte, the implant having a first sensitivity to the analyte before a foreign body response of the mammalian body and a second sensitivity less than the first sensitivity after the foreign body response of the mammalian body; and 
 delivering a second tissue response modifier from the second patch and through an epidermis of the mammalian body to reduce or eliminate the foreign body response of the mammalian body, the second tissue response modifier delivered such that the second tissue response modifier does not reach systemic levels in the mammalian body. 
 
     
     
       2. The method of  claim 1 , further comprising:
 receiving, from the implant and at a third patch placed on the mammalian body after the first patch, the signal associated with the analyte; and 
 delivering a third tissue response modifier from the third patch and through an epidermis of the mammalian body such that the third tissue response modifier does not reach systemic levels in the mammalian body. 
 
     
     
       3. The method of  claim 1 , further comprising:
 placing the first patch on the surface of the mammalian body; and 
 implanting the implant within the mammalian body after the first patch is placed on the surface of the mammalian body. 
 
     
     
       4. The method of  claim 1 , further comprising:
 placing the first patch on the surface of the mammalian body; and 
 removing the first patch prior to placing the second patch on the surface of the mammalian body. 
 
     
     
       5. The method of  claim 1 , wherein:
 delivering the first tissue response modifier includes injecting the first tissue response modifier from the first patch into the mammalian body through skin tissue disposed between the first patch and the implant such that the first tissue response modifier does not reach systemic levels in the mammalian body. 
 
     
     
       6. The method of  claim 1 , the method further comprising modulating an uptake of the first tissue response modifier using the first patch. 
     
     
       7. The method of  claim 1 , wherein the first patch includes at least one of an illuminator, a detector, a signal receiver, a signal transmitter, an energy storage component, or a data storage component. 
     
     
       8. The method of  claim 1 , further comprising removing the implant from the mammalian body after delivering the second tissue response modifier. 
     
     
       9. The method of  claim 1 , further comprising implanting the implant within the mammalian body, the implant including a hydrogel surrounding a sensing material, the hydrogel configured to be bioabsorbed by the mammalian body when the implant is within the mammalian body exposing the sensing material to a tissue of the mammalian body. 
     
     
       10. The method of  claim 1 , further comprising:
 placing the first patch on the surface of the mammalian body; 
 implanting the implant within the mammalian body after placing the first patch; and 
 removing the first patch from the surface of the mammalian body after delivering the first tissue response modifier from the mammalian body. 
 
     
     
       11. The method of  claim 1 , further comprising:
 removing the second patch from the surface of the mammalian body after receiving the signal; and 
 placing a third patch on the surface of the mammalian body after removing the second patch; and 
 receiving, from the implant and at the third patch, the signal associated with the analyte. 
 
     
     
       12. A method, comprising:
 implanting an implant within a mammalian body, the implant configured to measure an analyte of the mammalian body, the implant having a first sensitivity to the analyte before a foreign body response of the mammalian body and a second sensitivity less than the first sensitivity after the foreign body response of the mammalian body; 
 placing a first patch on a surface of the mammalian body over the implant; 
 receiving, from the implant and at the first patch, a signal associated with the analyte; 
 delivering, from the first patch, a first tissue response modifier through an epidermis of the mammalian body to reduce or eliminate the foreign body response of the mammalian body, the first tissue response modifier delivered such that the first tissue response modifier does not reach systemic levels in the mammalian body; 
 placing a second patch on the mammalian body after the first patch is placed on the surface of the mammalian body; 
 receiving, from the implant and at the second patch, the signal associated with the analyte; and 
 delivering, from the second patch, a second tissue response modifier through an epidermis of the mammalian body such that the second tissue response modifier does not reach systemic levels in the mammalian body. 
 
     
     
       13. The method of  claim 12 , wherein:
 the implant includes a sensing material configured to bind to the analyte and produce the signal in proportion to a quantity of the analyte, the foreign body response reducing an availability of the analyte to the sensing material; and 
 the first patch includes a detector that receives the signal from the sensing material of the implant. 
 
     
     
       14. The method of  claim 12 , wherein:
 the implant includes a sensing material configured to bind to the analyte and produce the signal in proportion to a quantity of the analyte, the foreign body response reducing an availability of the analyte to the sensing material; 
 the first patch includes a detector that receives the signal from the sensing material of the implant, the method further comprising: 
 illuminating the sensing material with an illuminator of the first patch such that the sensing material produces the signal in response to being illuminated. 
 
     
     
       15. The method of  claim 12 , wherein the first tissue response modifier includes at least one selection from a group consisting of a collagen inhibitor, an anti-fibrotic agent, an angiogenic agent, a vasculogenic agent, a pro-vascular dilation agent, an immunosuppressive agent, an anti-proliferative agent, an anti-migratory agent, an anti-inflammatory agent, a vasodilator, an anti-histamine, an anti-protein-fouling agent, a metabolic depressor, a synthetic molecule, a biologically produced molecule, a permeation enhancer, a gene therapy agent, a stem cell, a mammalian cell, and a drug. 
     
     
       16. The method of  claim 12 , further comprising delivering, from the first patch, at least one of radiation or pressure. 
     
     
       17. The method of  claim 12 , wherein:
 the implant includes a sensing material configured to bind to the analyte and produce the signal in proportion to a quantity of the analyte, the foreign body response reducing an availability of the analyte to the sensing material; and 
 the first patch includes a detector that receives the signal from the sensing material of the implant, the method further comprising: 
 transmitting, from an interrogator of the first patch, an interrogating signal through the epidermis to the sensing material of the implant. 
 
     
     
       18. The method of  claim 12 , wherein:
 the implant includes a sensing material configured to bind to the analyte and produce the signal in proportion to a quantity of the analyte, an effectiveness of the sensing material degraded when the analyte is impeded from reaching the sensing material by collagen; and 
 the first patch includes a detector that receives the signal from the sensing material of the implant. 
 
     
     
       19. The method of  claim 12 , wherein:
 the implant includes a sensing material configured to bind to the analyte and produce the signal in proportion to a quantity of the analyte, an effectiveness of the sensing material degraded when the analyte is impeded from reaching the sensing material by collagen; and 
 the first patch includes a detector that receives the signal from the sensing material of the implant; and 
 the first tissue response modifier inhibits the local accumulation of collagen. 
 
     
     
       20. The method of  claim 12 , wherein:
 implanting the implant includes implanting the implant within at least one of a dermis or a subcutis of a mammalian body. 
 
     
     
       21. The method of  claim 12 , wherein the implant includes a glucose-binding material configured to produce the signal in proportion to a quantity glucose, the foreign body response reducing an availability of glucose to the glucose-binding substance by reducing a local concentration of glucose below a systemic concentration of glucose. 
     
     
       22. The method of  claim 12 , further comprising removing the first patch from the mammalian body.

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